This is another slow week with the ongoing partial US government shut down. FDA published four guidance this week but these were not published in the Federal Register as is the usual requirement and practice. Look for these to show up when everyone goes back to work and digs out from the collection of activities that accumulated during the [...]
A detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since FY2013 Download your copy of this special report*: An Analysis of FDA FY2018 Drug GMP Warning Letters
Another slow week for FDA actions due to the partial government shutdown. No import alerts in the areas we cover, one draft guidance in the generics area though we don’t have the Federal Register publication yet. PIC/S, HPRA, and TGA had guidance published. A few recalls including a couple in the Class I category. One European report of GMP [...]
The FDA is still mostly furloughed except for safety issues. Others are back on a more normal post-holiday work effort. Nothing from the EMA or FDA in terms of guidance but a handful from TGA. Non-guidance items include those from MHRA, EMA, FDA, ICH and HPRA. We provide one warning letter issued to the Akorn Inc facility in Decatur [...]
Happy reading! Barbara FDA: DRUG: The FR announced availability of the final FDA guidance “Data Integrity and Compliance with Drug GMPs” PHARMACIES: The FR announced availability of a draft guidance ‘Current Good Manufacturing Practice – Guidance for human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act’ ADMINISTRATIVE: The FR published a proposed rule regarding the [...]
RISK FACTORS USED IN SCHEDULING FDA DRUG GMP INSPECTIONS The global supply chain for drug products sold in the US has become increasingly more complicated in the past decades. What was once a mostly domestic industry has become global including the sourcing of raw materials, APIs including their starting materials and intermediates, drug product manufacture, packaging, labeling, and distribution. [...]
Another short week with the New Year’s holiday, and the partial US government shutdown that impacts non-essential FDA activities. We have included a Special Report that can be downloaded in pdf on the Criteria for Drug Inspections. Hopefully a bit more back to normal next week! Happy Reading, Barbara FDA: none this week EMA: none this week OTHER: [...]
A very light holiday week, and the partial government shut down also took its toll on publications. Next week with the new years holiday will likely be similar. This week was essentially limited to recalls and import alerts. Happy Reading, Barbara FDA: none this week EMA: none this week OTHER: none this week MHRA published the following/updates: [...]